DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 08, 2026 has been entered.
2. Claims 2 and 12 have been cancelled. Claims 1, 3, 10 and 13 have been amended. Claims 5 and 14-24 were previously withdrawn as not being drawn to an elected species or invention.
3. Claims 1, 3, 4, 6-11 and 13 are currently being examined.
Specification
4. The disclosure is objected to because of the following informalities: on page 33, paragraph [00115], line 2 of the specification filed 04/13/2026, the specification recites “a supra Pfeiffer, 2013)”. It appears that this should be “a supra-lethal challenge (Pfeiffer, 2013)”.
Appropriate correction is required.
Priority
5. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/947,953, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. Examiner has established a priority date of 12/14/2020 for claims 1, 3, 4, 6-11 and 13 because the claims as currently constituted recite:
A method for enhancing an adaptive immune response in an initial viral infection in a subject in need thereof, the method comprising simultaneously administering prior to or during an initial viral infection in the subject a pharmaceutical composition comprising an effective amount of a therapeutic agent that blocks the activity of Type I interferon (IFN-I) and a pharmaceutical composition comprising an effective amount of an antigen, wherein the antigen is a live attenuated, replicating viral vaccine, wherein the therapeutic agent that blocks the activity of IFN-I is delivered as a single dose prior to or during the initial viral infection in the subject that transiently blocked blocks the activity of the IFN-I in the initial viral infection and protects against subsequent viral infections in the subject, and wherein the transient blockade of IFN-1 enhances the immune response and vaccine efficacy, whereby the adaptive immune response is enhanced in the subject during the initial and subsequent viral infection.
A review of the parent application 62/947,953 does not reveal support for the claimed method. Particularly the parent application does not provide support for enhancing an adaptive immune response in an initial viral infection in a subject in need thereof, the method comprising simultaneously administering prior to or during an initial viral infection in the subject, wherein the antigen is a live attenuated, replicating viral vaccine, and whereby the adaptive immune response is enhanced in the subject during the initial and subsequent viral infection.
Applicant is invited to submit evidence pointing to the serial number, page and line where support can be found establishing an earlier priority date.
New Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claims 1, 3, 4, 6-11 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the immune response" in the 3rd to last line. There is insufficient antecedent basis for this limitation in the claim because the antecedent portion of the claim recites an adaptive immune response.
Claim 1 recites the wherein/whereby clauses: wherein the transient blockade of IFN-1 enhances the immune response and vaccine efficacy, whereby the adaptive immune response is enhanced in the subject during the initial and subsequent viral infection. It is unclear from the combination of both of the wherein and whereby clauses if the transient blockade of IFN-1 can enhance any immune response and vaccine efficacy or if it is limited to enhancing the adaptive immune response during the initial and subsequent viral infection.
The dependent claims incorporate by reference the limitations of claim 1 and thus are also rejected.
New Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claims 1, 3, 4, 6-11 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection
Claim 1 has been amended to recite wherein the antigen is a live attenuated, replicating viral vaccine.
Applicant argues that support for the amendments to the claims can be found throughout the application as filed, for example at paragraphs [0004], [0005], [0007], [0009], [0051], the Examples, including [0094], [0097],[00110], [00115], [00139], and the Drawings.
A review of the cited support reveals support for replicating viral vaccines [0005] and [0009], live attenuated viral vaccines [0051], and replicating LCMV-HIV vectors [00139]. However, the cited support does not provide specific support for the wherein the antigen is a live attenuated, replicating viral vaccine.
The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112, first paragraph. See MPEP 2163.05 (II). See also In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (“Whatever may be the viability of an inductive-deductive approach to arriving at a claimed subgenus, it cannot be said that such a subgenus is necessarily described by a genus encompassing it and a species upon which it reads.”) Thus, the new limitation of wherein the antigen is a live attenuated, replicating viral vaccine is new matter because it is not supported by the as-filed disclosure.
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claim(s) 1, 3, 4, 6-8, 10-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Palacio et al. (J. Exp. Med. (Aug. 29, 2020) 217 (12): e20191220, pp. 1-14 and S1-S6, IDS), “Palacio” in view of Kallert et al. (Nat. Comm. 8:15327 | DOI: 10.1038/ncomms15327, pp. 1-13, May 26, 2017, IDS), “Kallert”.
Palacio teaches that they infected mice with viruses co-administered with a single dose of IFN-I receptor–blocking antibody to induce a short-term blockade of the IFN-I pathway. This resulted in a transient “spike” in antigen levels, followed by rapid antigen clearance. Palacio teaches that short-term IFN-I blockade after coronavirus, flavivirus, rhabdovirus, or arenavirus infection induced a long-lasting enhancement of immunological memory that conferred improved protection upon subsequent reinfections. Short-term IFN-I blockade also improved the efficacy of viral vaccines. These findings demonstrate a novel mechanism by which IFN-I regulate immunological memory and provide insights for rational vaccine design. See abstract.
Palacio teaches IFN-I blockade during lymphocytic choriomeningitis virus (LCMV)–simian immunodeficiency virus (SIV) vaccination significantly increased antibody-mediated SIV neutralization compared with control, as measured by in vitro neutralization assays (Fig. S1 E). Palacio teaches in the context of LCMV-HIV vaccination, short-term IFN-I blockade facilitated germinal center B cell responses (Fig. S1 F),which suggested that antibody diversification was improved. See p. 3-left column.
Palacio teaches IFN-I blockade resulted in a 17-fold improvement in HIV-1 cross-reactive humoral immunity after vaccination (Fig. S1 G) and improved cytokine co-expression by HIV specific T cells compared with control vaccination (Fig. S1, I–M). See p. 3-right column.
Palacio teaches IFN-I blockade during an initial viral prime improves future host protection following future reinfections. See pp. 7-9 and Figs. 6 and S5.
Palacio teaches LCMV-expressing SIVmac239 antigens (HIV Gag and Env), GFP, or OVA were produced as described previously (Kallert et al., 2017). See p. 11-Viruses.
Palacio teaches constructing replicating LCMV-HIV vectors. See p. 11-Viruses,
Palacio teaches that the IFN-I receptor–blocking antibody is MAR1-5A3. See p. 10-Materials and methods-left column.
Palacio teaches that the MAR1-5A3 antibody was administered, admixed together with each viral vector vaccine as a single bolus. See p. 10-Materials and methods-left column.
Palacio teaches as set forth above, but does not teach that the viral vaccines were attenuated, replicating viral or administering the MAR1-5A3 antibody separately from the vaccine.
Kallert teaches that lymphocytic choriomeningitis virus (LCMV) can be engineered to serve as a replication competent, stably-attenuated immunotherapy vector (artLCMV). artLCMV delivers tumor-associated antigens to dendritic cells for efficient CTL priming. Kallert teaches unlike replication-deficient vectors, artLCMV targets also lymphoid tissue stroma cells expressing the alarmin interleukin-33. By triggering interleukin-33 signals, artLCMV elicits CTLeff responses of higher magnitude and functionality than those induced by replication-deficient vectors leading to superior anti-tumor efficacy. See Abstract and Figures 1-7.
Kallert teaches that replicating live approaches are being used in vaccine approaches for viral infections like immunodeficiency virus infection. Kallert teaches that infectious diseases and cancer have in common that potency is rate-limiting, outweighing potential concerns related to the safety profile of replicating vector systems or to the release of genetically modified organisms into the environment. Accordingly, the safety profile of genetically engineered live viruses has become acceptable for oncolytic virus therapy.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Palacio and Kallert and use the replication competent, stably-attenuated immunotherapy vector artLCMV in the methods of Palacio because Palacio teaches using the methods of Kallert to produce the LCMV vectors and Kallert teaches the benefits of the artLCMV vectors of improved activity and safety. Thus, one would have been motivated to use the artLCMV vectors in the method of Palacio to vaccinate against viral infections in combination with the IFN-I blockade given the benefits of the artLCMV taught by Kallert.
Additionally, it would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to administer the IFN-I blockade antibody and the viral vaccine vectors together or separately to optimize treatment and control for any side effects of the treatment as needed. Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See MPEP 2144.04 (IV)(C).
9. Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Palacio et al. (J. Exp. Med. (Aug. 29, 2020) 217 (12): e20191220, pp. 1-14 and S1-S6, IDS), “Palacio” in view of Kallert et al. (Nat. Comm. 8:15327 | DOI: 10.1038/ncomms15327, pp. 1-13, May 26, 2017, IDS), “Kallert” as applied to claims 1, 3, 4, 6-8, 10-11 and 13 above, and further in view of US 2022/0125919 A1 (Jooss et al Apr. 28, 2022, file Nov. 7, 2019, of record). .
Palacio and Kallert teach as set forth above, but do not teach using anifrolumab as the IFN-I blockade antibody.
Jooss teaches methods associated with alphavirus-based expression platforms and co-administration of an inhibitor of Type I interferon signaling.
Jooss teaches that inhibitors of Type I interferon signaling includes the antibodies MAR1-5A3 and anifrolumab. See ¶¶ 0039, 0426-0428 and claims 25-29.
Jooss teaches administering a vaccine prior to, concurrently or subsequent to administration of the inhibitor of Type I interferon. See ¶¶ 0079, 0142 and 0271-0284 and 0428, and claims 150-157.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Palacio, Kallert and Joos and use anifrolumab as the IFN-I blockade antibody in the methods of Palacio and Kallert because Joos teaches that that anifrolumab is an inhibitor of type I interferon signaling like MAR1-5A3. Thus, it would have been obvious to one of skill in the art to substitute anifrolumab for MAR1-5A3 given they both block IFN-I and can be added in any order with the vaccine as taught by Joos.
Conclusion
10. All other objections and rejections recited in the Office Action of January 20, 2026 are withdrawn in view of Applicant’s amendments and arguments.
11. No claims allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached M-F 8:30-5:30 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Greg Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER J REDDIG/ Primary Examiner, Art Unit 1646
Prosecution Insights